Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS
Part of paid clinical trials in Cleveland, Ohio.
- Sponsor
- The Cleveland Clinic
- Study ID
- NCT07442747
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Deep Brain Stimulation
- Parkinson's Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Exercise — BEHAVIORALParticipants will complete an eight-week control period followed by an eight-week cycling program. They will complete 3 sessions per week in-person with a member of the study team, for a total of 24 exercise sessions.
Study Details
This study is focused on people with Parkinson's disease who already have deep brain stimulation devices. The goal is to understand how aerobic exercise, specifically forced vs voluntary cycling, affects movement, thinking, and brain activity in these individuals. Parkinson's disease is a progressive condition that impacts both movement and cognitive function. Previous research suggests aerobic exercise can improve PD symptoms, but the mechanisms underlying the improvement are not fully understood. This study aims to evaluate the neural (brain) mechanisms underlying exercise.
Key Dates
- First listed
- Mar 2, 2026
- Start date
- Jul 8, 2026
- Status verified
- Jul 2026
- Primary completion
- Dec 31, 2029
- Completion
- Dec 31, 2029
Study Design
- Enrollment
- 36 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Forced Exercise (FE)Participants in the forced exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program using a stationary bike equipped with a motor that assists pedaling. The motor helps maintain a cadence higher than the participant's voluntary pace, typically around 80-90 revolutions per minute, while the participant continues to actively pedal. Each session lasts about 40 minutes and occurs three times per week under supervision of an exercise professional. Heart rate will be monitored to ensure safety and maintain aerobic intensity. The goal is to provide consistent, high-rate cycling that participants likely could not achieve on their own.
- Experimental: Voluntary Exercise (VE)Participants in the voluntary exercise group will complete an eight-week control period where they will be asked to maintain their usual activities and wear an activity monitoring device. This will be followed by an eight-week cycling program on a standard stationary bike. They will cycle at a self-selected pace while maintaining a target heart rate to ensure aerobic intensity. Each session lasts about 40 minutes and occurs three times per week under supervision of an exercise professional. Heart rate will be monitored for safety and consistency.
Primary Outcome Measure
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination) [ Time Frame: Baseline to EOT and Baseline to EOT+4 weeks ]
Central Contacts
- MacKenzie Dunlap216-219-3949
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | Jay L Alberts, PhD (PRINCIPAL_INVESTIGATOR) Anson Rosenfeldt, PT, DPT, MBA (PRINCIPAL_INVESTIGATOR) |
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